Intravascular implants and methods of using the same

ABSTRACT

An intravascular implant and methods of using the implant within the vasculature of the body, for example near a vascular aneurysm, are disclosed. A method of treating an aneurysm includes positioning a vascular graft comprising a tubular channel having a first end and a second end in a blood vessel, securing the vascular graft in place with an expandable anchoring member, and filling a seal cuff on the vascular graft, wherein the seal cuff extends radially outward beyond an exterior surface of the vascular graft, wherein the seal cuff comprises a first seal portion and a second seal portion and wherein the first seal portion is separated from the second seal portion by a first gap and a second gap along a circumference of the seal cuff.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/284,381 filed Oct. 3, 2016, which is a continuation of U.S. patentapplication Ser. No. 13/666,756 filed Nov. 1, 2012 (now U.S. Pat. No.9,615,912), which is a continuation of U.S. patent application Ser. No.11/351,423 filed Feb. 10, 2006 (now abandoned), which is a continuationof U.S. patent application Ser. No. 10/778,870 filed Feb. 12, 2004 (nowabandoned), which claims the benefit of U.S. Provisional Application No.60/447,056 filed Feb. 12, 2003, the contents of all which areincorporated herein by reference in their entireties.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates generally to an intravascular implant andmethods of using the implant within the vasculature of the body,particularly adjacent to vascular aneurysms. The present invention alsorelates to the attachment of a second implant, such as a vascular graft,to the intravascular implant.

2. Description of the Related Art

An aneurysm is an abnormal dilatation of a biological vessel. Aneurysmscan alter flow through the affected vessel and often decrease thestrength of the vessel wall, thereby increasing the vessel's risk ofrupturing at the point of dilation or weakening. Implanting a vascularprosthesis through the vessel with the aneurysm is a common aneurysmtherapy. Vascular grafts and stent grafts (e.g., ANEURX® Stent GraftSystem from Medtronic AVE, Inc., Santa Rosa, Calif.) are examples ofvascular prostheses used to treat aneurysms by reconstructing thedamaged vessel.

Stent grafts rely on a secure attachment to the proximal, or upstream,neck of an aneurysm, particularly for aortic abdominal aneurysms (AAA),but several factors can interfere with this attachment. The proximalneck of the aneurysm can be diseased. This diseased tissue can by acalcified and/or irregularly shaped tissue surface for which the graftmust to attach. Healthy, easily-attachable tissue is often a distanceaway from the aneurysm. For example, in AAAs the nearest healthyvascular tissue may be above the renal arteries. Even a healthy vesselcan be so irregularly shaped or tortuous that a graft may havedifficulty attaching and staying sealed. Furthermore, the proximal neckcan shift locations and geometries over time, particularly over thecourse of aneurysm treatment and reformation of the aneurysmal sack.This shifting and shape changing of the vessel can result in partial ortotal dislodgement of the proximal end of a currently available stentgraft.

Devices have been developed that attempt to solve the issue of vasculargraft attachment. International Publication No. WO 00/69367 by Streckerdiscloses an aneurysm stent. The stent has a securing mechanism thatattaches to the vascular wall proximal to the renal arteries, which istypically where healthier vascular tissue is located when a patient hasan AAA. The stent also has a membrane that is placed at the proximal endof a stent graft and forms a seal in the vessel. Strecker, however,discloses a securing mechanism with ball-ended struts which angle awayfrom the seal. The ball-ends will reduce the pressure applied by thestruts onto the vascular wall, and the struts are angled improperly toinsure the best anchor. If the graft begins to dislodge into theaneurysm, the struts will tend to fold inward and slide with the graftinstead of engaging frictionally into the vascular walls to preventdislodgement.

U.S. Pat. No. 6,152,956 to Pierce discloses a radially expandable collarconnected by connecting wires to an expandable stent. The stent also hasbarbs with sharp ends that spring radially outward to embed into thewalls of the vascular tissue. The stent, however, is expandable, butonce expanded cannot be easily contracted. The stent, therefore, can notbe repositioned if incorrectly placed during initial deployment.Further, the barbs do not angle toward the seal and will not engage intothe vascular wall for additional anchoring force, should the prosthesisbegin to become dislodged.

U.S. Pat. No. 6,361,556 by Chuter discloses a stent for attaching tografts, where the stent is connected to an attachment system foranchoring to the vessel. The attaching system has hooks angled towardthe graft. The attachment system has no way of being repositioned duringdeployment. Further, the stent is a substantially rigid, balloonexpandable stent and therefore maintains a fixed diameter and resistsdeformation from forces imposed by the vascular environment. The stent,therefore, can not be easily repositioned during deployment and may notseal the graft under changing geometric conditions over time.

There is thus a need for a device and method that can securely anchor avascular graft within a vessel and can seal the graft regardless of theexistence of diseased tissue at the sealing location. There is also aneed for a device that can be deployed to the vasculature whileminimizing bloodflow obstruction to the main vessel and to branchingvessels. A need also exists for a device and method that can accomplishthe above needs and adjust to tortuous vasculature. There is also a needfor a device and method that can accomplish the above and havedimensions and a placement location that can be adjusted multiple timesin vivo, even after the anchor has been fully deployed. There is also aneed for a device that can be delivered through a low profile catheter.Additionally, there is a need for a device that can anchor into adifferent portion of tissue from which it seals, so as not to overstressany individual portion of vascular tissue or any elements of theimplant, thus preventing fractures in the tissue and of the implant.

BRIEF SUMMARY OF THE INVENTION

One embodiment of the disclosed intravascular implant has a seal, aconnector, and an anchor. The seal is configured to attach to a secondimplant. The connector has a first end and a second end. The first endis attached to the seal, and the second end is attached to the anchor.The anchor has an arm, and the arm is angled toward the seal as the armextends radially away from the center of the anchor. The anchor can beformed of multiple radially extending tines or arms such as an uncoveredumbrella structure, a hook and/or a barb.

Another embodiment of the disclosed intravascular implant has a seal anda substantially cylindrical coil, where the coil is attached to, andextends from, the seal. The seal can also have a gasket. The seal canalso have an inflatable collar.

Yet another embodiment of the intravascular implant has a seal, aconnector and an anchor. The seal is configured to attach to a secondimplant. The connector has a first end and a second end and may beflexible. The first end is attached to the seal, and the second end isattached to the anchor. The connector may be formed of a coil. Theconnector can be configured to allow for longitudinal adjustments. Thedistance between the seal and the anchor can be changed. The implant canalso have a second anchor to assist in additional fixation.

Another embodiment of the intravascular implant has a seal, a connector,an anchor, and a stop. The connector has a first end and a second end.The first end is attached to the seal, and the second end is attached tothe anchor. The anchor has an arm and the arm is angled toward the sealas the arm extends radially from the center of the anchor. Radialextension of the arm is limited by the stop. The stop can be amechanical interference.

Yet another embodiment of the disclosed intravascular implant has aseal, a connector and an anchor. The connector has a flexible member, afirst end and a second end. The first end is attached to the seal andthe second end is attached to the anchor. The anchor has an arm. The armangles toward the seal as the arm extends radially from the center ofthe anchor. The seal can have a gasket. The seal can have an inflatablecollar. The connector can have a coil. The implant can also have asecond anchor.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front perspective view of an embodiment of the intravascularimplant.

FIGS. 2 and 3 are front perspective views of various embodiments of theseal.

FIG. 4 is a top view of an embodiment of the seal ring.

FIGS. 5-8 are front perspective views of various embodiments of theseal.

FIGS. 9 and 10 are a top and a side view, respectively, of theembodiment of the seal ring shown in FIG. 8.

FIGS. 11 and 12 are front perspective views of various embodiments ofthe seal ring.

FIG. 13 illustrates an embodiment of cross-section A-A of theintravascular implant without the seal.

FIG. 14 is a front perspective view of an embodiment of theintravascular implant.

FIG. 15 is a perspective view of an embodiment of the attachment device.

FIG. 16 illustrates an embodiment of cross-section B-B of the seal withthe connectors.

FIG. 17 is a front perspective view of an embodiment of the connectorand the attachment device.

FIGS. 18-20 illustrate embodiments of the connector.

FIGS. 21-23 are front perspective views of various embodiments of theintravascular implant.

FIGS. 24 and 25 are front perspective views of various embodiments ofthe anchor.

FIG. 26 is a top view of an embodiment of the anchor.

FIGS. 27-29 illustrate various embodiments of the intravascular implant.

FIG. 30 illustrates an embodiment of a method for compressing the sealring for deployment.

FIGS. 31-33 illustrate an embodiment of a method for deploying theintravascular implant into a vascular site.

FIGS. 34-37 illustrate various embodiments of radially contracting andexpanding the anus of the anchor.

FIG. 38 illustrates an embodiment of a method for deploying theintravascular implant into a vascular site.

FIG. 39 illustrates an embodiment of a method for deploying the secondimplant with the intravascular implant.

FIGS. 40-42 illustrate an embodiment of a method for attaching the sealto the attachment device.

FIG. 43 illustrates an embodiment of the second implant.

FIGS. 44 and 45 illustrate an embodiment of a method for attaching theseal to the attachment device.

FIG. 46 illustrates an embodiment of the intravascular implant afterdeployment into a vascular site.

DETAILED DESCRIPTION

FIG. 1 illustrates an embodiment of an intravascular implant 2. Theimplant 2 can have a connector 4 having a first end 6 and a second end8. The first end 6 can be attached to an anchor 10. The anchor 10 canhave a central tip 12. The central tip 12 can be attached to the firstend 6. The anchor 10 can also have multiple tines or arms 14 extendingradially from the central tip 12, such as in an uncovered umbrellastructure. The central tip 12 can be rotatably or flexibly attached tothe arms 14. Leaves 16 can be attached at two ends to adjacent anus 14.A flow-through area 18 can be an open port defined by any leaf 16 andthe arms 14 to which that leaf 16 attaches.

The second end 8 can be attached to a seal 20. The second end 8 canattach to the seal 20 through an attachment device 22, for examplestruts. The attachment device 22 can be integral with the second end 8,integral with the seal 20, or an independent part. Attachment devices 22can also be used to attach the connector 4 to the anchor 10. The seal 20can have a first proximal end 24 and a first distal end 26. A secondimplant 28 can be attached to the seal 20, for example at the distal end26, or the second implant 28 can be an integral part of the seal 20.

FIG. 2 illustrates a single gasket embodiment of the seal 20. The seal20 can have a first seal ring 30 at the proximal end 24. The seal 20 canalso have a second seal ring 32 at the distal end 26. The seal rings 30and 32 can have radially extending spring force elements or tissuemainstays 33. The tissue mainstays 33 can be, for example a barb, spike,hook, peg, a coil, pigtail or leaf spring, or any combination thereof.The seal rings 30 and 32 can be made from nickel-titanium alloy (e.g.,Nitinol), titanium, stainless steel, cobalt-chrome alloy (e.g., ELGILOY®from Elgin Specialty Metals, Elgin, Ill.; CONICHROME® from CarpenterMetals Corp., Wyomissing, Pa.), polymers such as polyester (e.g.,DACRON® from E.I. Du Pont de Nemours and Company, Wilmington, Del.),polypropylene, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE),polyether ether ketone (PEEK), nylon, extruded collagen, silicone,radiopaque materials, or any combination thereof. Examples of radiopaquematerials are barium, sulfate, titanium, stainless steel,nickel-titanium alloys and gold.

The seal 20 can have a first seal cover 34 attached at the proximal end24 to the first seal ring 30 and at the distal end 26 to the second sealring 32. The seal cover 34 can be made from polymers such as polyester(e.g., DACRON® from E.I. Du Pont de Nemours and Company, Wilmington,Del.), polypropylene, PTFE, ePTFE, PEEK, nylon, polylactic acid (PLA),poly(lactic-co-glycolic acid) (PLGA), polyglycolic acid (PGA),polyurethane, polyethylene, vascular, valvular or pericardial tissue,extruded collagen, silicone, metal mesh, radiopaque materials, or anycombination thereof.

A seal flow port 36 can be the hole defined by the inner radii of theseal rings 30 and 32 and the seal cover 34. The seal 20 can have a sealdiameter 38 that can depend on the diameter of the vessel in a givenpatient. The seal diameter 38 can be from about 5 mm (0.2 in.) to about50 mm (2.0 in.), for example about 30 mm (1.2 in.). The seal 20 can havea seal height 40 from about 1 mm (0.04 in.) to about 6 cm (2.4 in.).

FIG. 3 illustrates an embodiment of the seal 20 that can have a firstgasket 42 and a second gasket 44. Such a design can incrementallydecrease the pressure across a given length so no one gasket 42 or 44endures the entire pressure. The first gasket 42 can be similar to asingle gasket seal embodiment illustrated in FIG. 2, except that thefirst seal cover 34 can be attached to the second seal ring 32 at afirst gasket distal end 46. The second gasket 44 can have a second sealcover 48. The second seal cover 48 can be attached at a second gasketproximal end 50 to the second seal ring 32 and/or the second seal cover48 can be integral with the first seal cover 34. The second seal cover48 can also attach at the distal end 26 to a third seal ring 52.

FIG. 4 illustrates an embodiment of the seal rings 30, 32 and 52 (shownas 30). The seal ring 30 can have diametrically opposed thin sections 54and diametrically opposed thick sections 56. The seal ring 20 can have aseal ring thickness 58 that can vary from a minimum in the thin sections54 to a maximum in the thick sections 56. The seal ring 30 can also havea constant thickness along the entire circumference of the seal ring 30.The seal ring 30 can also have a gap in the circumference of the sealring 30, forming a “c”-ring (not shown) as known to one having ordinaryskill in the art.

FIG. 5 illustrates an embodiment of the seal 20 that can have a sealvolume 60. The seal volume 60 can be a bladder or collar filled by afluid, for example saline, plasma, helium, oxygen, radiopaque materials(including small pieces of solids), blood, epoxy, glue, or anycombination thereof. The bladder can be inflated in vivo by a methodknown to those having ordinary skill in the art. The seal volume 60 canalso be a solid, for example polymers such as polyester (e.g., DACRON®from E.I. Du Pont de Nemours and Company, Wilmington, Del.),polypropylene, PTFE, ePTFE, PEEK, nylon, polylactic acid (PLA),poly(lactic-co-glycolic acid) (PLGA), polyglycolic acid (PGA),polyurethane, polyethylene, vascular, valvular or pericardial tissue,extruded collagen, silicone, radiopaque materials, or any combinationthereof.

A first and/or second seal flow ports 62 and 64, respectively, can bedefined, for example as cylinders, within the seal volume 60. Oncedeployed, multiple seal flow ports 62 and 64 can attach to multiplesecond implants 28, or multiple legs of the second implant 28 that canextend distal of the seal into the iliac arteries. A connector port 66can also be defined, for example as a cylinder, within the seal volume60. The second end 8 of the connector 4 can be placed into the connectorport 66. The seal volume 60 can be inflated after the second end 8 isplaced into the connector port 66 to constrict and pressure fit theconnector port 66 around the second end 8, thereby fixedly attaching theseal 20 to the connector 4.

FIG. 6 illustrates an embodiment of the seal 20 that can have a helicalseal coil 68 having a first end 70 and a second end 72. The ends 70 and72 can be dulled, for example by attaching small balls as shown. Theseal coil 68 can have a number of turns 74, for example from about 1.25turns 74 to about 50 turns 74, for example about 5 turns 74.

FIG. 7 illustrates an embodiment of the seal 20 that can have astructure similar to the anchor illustrated in FIG. 1 but with avertically inverted orientation.

FIG. 8 illustrates an embodiment of the seal 20 that can have a firstseal ring 30 and a second seal ring 32 that are mechanically insulatedfrom each other. This structure enables the seal rings 30 and 32 to fitto more easily fit and seal an irregularly shaped vessel.

A first hub 76 can be fixedly attached or rotatably attached to firstseal struts 78 and a center beam 80. The first seal struts 78 canslidably connect on the outside or inside of the first seal ring 30 atfree points 82. The first seal struts 78 can be fixedly or rotatablyattached to the second seal ring 32 at fixation points 84. The firstseal struts 78 can be fixedly attached or rotatably attached to a firstcollar 86. The first collar 86 can be slidably attached to the centerbeam 80.

A second hub 88 can be fixedly attached or rotatably attached to secondseal struts 90 and the center beam 80. The second seal struts 90 canslidably connect on the outside or inside of the second seal ring 32 atthe free points 82. The second seal struts 90 can be fixedly orrotatably attached to the first seal ring 30 at the fixation points 84.The second seal struts 90 can be fixedly attached or rotatably attachedto a second collar 92. The second collar 86 can be slidably attached tothe center beam 80. The seal struts 78 and 90, the hubs 76 and 88, andthe collars 86 and 92 can be from the same materials as the seal rings30, 32 and 52.

The seal rings 30 and 32 can be wave-shaped. FIG. 9 illustrates a topview of one embodiment of the wave-shaped seal ring 30, showing acircular shape from above. FIG. 10 illustrates a side view of thewave-shaped seal ring 30 illustrated in FIGS. 8 and 9, showing twoperiods of smooth oscillation in a seal ring height 94.

FIG. 11 illustrates an embodiment of the seal ring 30 that can havesharp oscillations in the seal ring height 94. Angled seal ring struts96 can form the seal ring 30 into a zigzag. FIG. 12 illustrates a sealring 30 that can have a combination of alternating lock zones 98 andangled seal ring struts 96. The lock zones 98 can be substantiallyparallel to the circumference of the seal ring 30.

FIG. 13 illustrates an embodiment of cross-section A-A (shown in FIG. 1)of the intravascular implant 2 without the seal 20. The anchor 10 canhave connectors 4 attached to the arms 14. The second end 8 of eachconnector 4 can have an integral attachment device 22. The attachmentdevice 22 can be made of a slide 100 and an interference piece 102defining a catch 104 there between. The slide 100 can have a slide angle106 from about 90° to about 180°. The slide 100 can also have a slideheight 108 from about 0.38 mm (0.015 in.) to about 6.35 mm (0.250 in.),for example about 3.18 mm (0.125 in.). The interference piece 102 canhave an interference piece depth 110 from about 0.38 mm (0.015 in.) toabout 4.95 mm (0.195 in.). The slide 100 and interference piece 102 canbe from the same materials as the seal rings 30, 32 and 52 or sealcovers 34 and 48.

FIG. 14 illustrates an embodiment of the intravascular implant 2. Theanchor 10 can have a solid ring, and can be fixedly or rotatablyattached to about two or more connectors 4. The seal ring 30 can bevertically surrounded by the slides 100 and the interference pieces 102.The seal ring 30 can, therefore, be engaged in the catch 104 and fixedlyattached to the connectors 4.

FIG. 15 illustrates an embodiment of the attachment device 22. Theattachment device 22 can have first and second slides 100 a and 100 b,first and second interference pieces 102 a and 102 b, a catch 104defined by the slides 100 a and 100 b and the interference pieces 102 aand 102 b. The attachment device 22 can also have a rod slot 112 definedbetween the first slide 100 a and second slide 100 b, and between thefirst interference piece 102 a and the second interference piece 102 b.

FIG. 16 illustrates an embodiment of cross-section B-B (shown in FIG. 6)of the seal 20. The two turns of the coil 68 can define the catch 104.The coil 68 can have a coil wire diameter 114 from about 0.03 mm (0.001in.) to about 1.3 mm (0.050 in.), for example about 0.64 mm (0.025 in.).

FIG. 17 illustrates an embodiment of the connector 4 that can beattached to the attachment devices 22, that can be, in turn, attached tothe seal 20. The connector 4 can be a flexible wire, coil, rod orcombinations thereof and can be hollowed. The connector 4 can also bethreaded to rotatably fit the anchor 10 and seal 20 or attachment device22. The connector can be made from any material listed for the anchor10.

The attachment devices 22 can be wires, coils, rods or combinationsthereof. The connector 4 can also be directly attached to the seal 20.The connector 4 can be attached to the attachment devices 22 at aconnector interface 116. The connector interface 116 can have a hub,slider, or collar. The connector interface 116 can be a directattachment. The connector 4 and attachment device 22 can also be anintegral part. The seal 20 and attachment device 22 can also be anintegral part.

FIG. 18 illustrates an embodiment of the connector 4 that can be madefrom a helical connector coil 118. The connector coil 118 can be madefrom a wire, for example a guidewire, having a diameter from about 0.46mm (0.018 in.) to about 2.54 mm (0.100 in.). FIG. 19 illustrates anembodiment of the connector 4 that can be made from the connector coil118 and a connector wire or rod 120. The connector wire or rod 120 canalso be made from a wire, for example a guidewire, having a diameterfrom about 0.46 mm (0.018 in.) to about 2.54 mm (0.100 in.). FIG. 20illustrates an embodiment of the connector 4 that can have sharposcillations in connector width. Angled connector struts 124 can formthe connector 4 into a zigzag.

FIG. 21 illustrates an embodiment of the intravascular implant 2 thatcan a longitudinal axis 126. The attachment device 22 can attach theconnector 4 to the anchor 10 such that the first end 6 can besubstantially on the longitudinal axis 126. The second end 8 can attachto the seal 20 substantially along a radial perimeter of the seal 20.

FIG. 22 illustrates an embodiment of the intravascular implant 2 thatcan have the attachment device 22 attach the connector 4 to the seal 20such that the second end 8 can be substantially on the longitudinal axis126. The first end 6 can attach to the anchor 10 substantially along aradial perimeter of the anchor 10.

FIG. 23 illustrates an embodiment of the intravascular implant 2 thatcan have multiple connectors 4. The connectors 4 can rotatably orfixedly attach to each other near their centers at joint points 128.Joined pairs of connectors 4 can form x-beams 128. The x-beams 128 candefine transverse flow ports 132.

FIG. 24 illustrates an embodiment of the anchor 10 shaped as a helicalanchor coil 134 having a first end 136 and a second end 138. The ends136 and 138 can be dulled, for example by attaching small balls asshown. The seal coil 134 can have from about 1 turn 140 to about 10turns 140, for example about 4 turns 140. The anchor 10 can also have ananchor width 142 from about 5 mm (0.2 in.) to about 50 mm (2 in.). Theanchor 10 can also have an anchor height 144.

FIG. 25 illustrates an embodiment of the anchor 10. The anchor 10 canhave the central tip 12, the arms 14, and the leaves 16 as shown anddescribed in FIG. 1. The arms 14 can also extend radially beyond eachattachment point 146 of each arm 14 and each leaf 16 to form adiminishing spring force element or tissue mainstay 148. The springforce elements or tissue mainstays 148 on the anchor 10 can be the samematerial and design as the tissue mainstays 33 on the seal 20, and viceversa. Anchor collar 150 can be slidably mounted to the connector 4 toradially extend or contract the arms 14 and to adjust the height betweenthe anchor 10 and the seal 20 to better place the implant 2 with regardto the transverse vessels, for example the renal arteries, and vascularwall abnormalities. The anchor collar 150 can be fixedly or rotatablyattached to arm supports 152. The arm supports 152 can be fixedly orrotatably attached to the arms 14 at support points 154. The armsupports 152 can also be an integral part of the anchor collar 150and/or the arms 14. The central tip 12, arms 14, leafs 16, mainstays148, and arm supports 152 can be made from the same materials listed forthe seal rings 30, 32 and 52.

FIG. 26 illustrates a top view of an embodiment of anchor 10. Each leaf16 can have a first leaf end 156 and a second leaf end 158. The firstleaf end 156 of one leaf 16 can merge with the second leaf end 158 ofthe neighboring leaf 16 and the intermediate arm 14 into a cover 160.The cover 160 can be a cylinder with two open ends. The leaf 16, firstleaf end 156, second leaf end 158 and cover 160 can be fixedly orrotatably attached. The first leaf end 156 and the second leaf end 158can terminate within the cover 160. When deployed, the leaf 16 can pressagainst the vascular wall to maintain a substantially circularcross-section of the vessel.

FIG. 27 illustrates an embodiment of the intravascular implant 2 havingthe arms 14 supported at support points 154 by the connectors 4. Theseal 20 can also be radially collapsible and expandable. FIGS. 28 and 29illustrate embodiments of the intravascular implant 2 that can have afirst anchor 10 and a second anchor 162. The second anchor can befixedly or rotatably attached to connectors 4 at support points 154. Thesecond anchor 162 can also be vertically inverted with respect to thefirst anchor, as shown in FIG. 29.

Methods of Manufacture

The tissue mainstays 33, shown in FIG. 2, can be directly attached tothe seal rings 30, 32 or 52 by, for example, melting, screwing, gluing,welding or use of an interference fit or pressure fit such as crimping,or combining methods thereof, to join the connector 4 to the seal 20.The tissue mainstays 33 and the seal rings 30, 32 or 52 can beintegrated, for example, by die cutting, laser cutting, electricaldischarge machining (EDM) or stamping from a single piece or material.The connector interface 116, shown in FIG. 17, can also directly attachto the connector 4 and the seal 20 or be integrated thereto by anymethod listed for the tissue mainstays 33 and the seal rings 30, 32 or52. The arm supports 152, shown in FIG. 25, can also be integrated withthe anchor collar 150 and/or the arms 14 by any method listed for thetissue mainstays 33 and the seal rings 30, 32 or 52. As shown in FIG.26, the leaf 16, first leaf end 156, second leaf end 158 and cover 160can be fixedly or rotatably attached or integrally formed by any by anymethod listed for the tissue mainstays 33 and the seal rings 30, 32 or52.

As shown in FIG. 19, the connector coil 118 and connector rod 120 can beattached at the first connector end 6 and the second connector end bymethods known to one having ordinary skill in the art.

Integrated parts can be made from pre-formed resilient materials, forexample resilient alloys (e.g., Nitinol, ELGILOY®) that are preformedand biased into the post-deployment shape and then compressed into thedeployment shape.

Any elongated parts used in the intravascular implant 2 and the secondimplant 28, for example the tip 12, the arms 14, the leafs 16, theattachment devices 22, the seal rings 30, 32 and 52, the seal coil 68,the connector coil 118, the connector rod 120, the connector strut 124,the anchor coil 134 and the arm supports 152, can be ovalized, or havean oval cross section where necessary, to ease crimping with otherparts.

Method of Use

The intravascular implant 2 can be collapsed or compressed into adeployment configuration to enable minimally invasive implantation intothe vasculature of a patient. FIG. 30 illustrates one embodiment ofcompressing the seal ring 30, as shown in FIG. 4, by applying outwardradial forces, as shown by arrows 164, to the thin sections 54 and/or byapplying an inward radial force, as shown by arrows 166, to the thicksections 56. Other embodiments can be compressed by applying inwardradial forces spread around the circumference of the implant and/orother methods known to those having ordinary skill in the art.

The intravascular implant 2 can be loaded into a delivery catheter 168by methods known to those having ordinary skill in the art. Because thedesign of the intravascular implant 2 can separate the anchor 10 fromthe seal 20, a low profile catheter can be used to deliver theintravascular implant 2. As illustrated in FIG. 31, the deliverycatheter 168 can be positioned, as shown by the arrow, at a vascularsite 170 using a guidewire (not shown) and an “over-the-wire” deliverymethod, known to those having ordinary skill in the art. A control line172 can also extend distally from the implant 2. The control line 172can include controls used to manipulate any part of the intravascularimplant 2 such as rotating the seal 20, expanding or contracting thearms 14, or separating delivery devices from the implant 2, and/or todeliver a substance such as a medication or radiopaque material, and/orto receive signals such as optical or electrical signals. The vascularsite 170 can be adjacent to a vascular aneurysm 174, for example anabdominal aortic aneurysm, having a proximal neck 176 and transversevessels 180, for example renal arteries, proximal to the vascularaneurysm 174.

FIG. 32 illustrates that the catheter 168 can be partially distallyretracted, as shown by arrows 182, thereby exposing the arms 14 whileretaining the seal 20. Once exposed, the arms 14 can expand radially, asshown by arrows 184. Expansion of the arms 14 can occur due to resilientmaterial expansion or mechanical manipulation. The tissue mainstays 148can seat in the wall of the vascular site 170 proximal to the transversevessels 180, preventing the anchor 14 from moving distally. Multiple,independent arms 14 can adjust to the surrounding vasculature geometryto fit as needed for secure attachment to the vascular wall. Thedistance between the central tip 12 and the seal 20 can be an effectiveconnector length 186. The effective connector length 186 can be adjustedafter the tissue mainstays 148 have been seated in the wall of thevascular site 170. The effective connector length 186 can be adjusted byrotating the seal 20, as shown by arrows 188, along a threaded connector4.

FIG. 33 illustrates that the arms 14 can be contracted, as shown byarrows 190. The anchor 10 can then be easily repositioned, as shown byarrows 192. The intravascular implant 2 can be made from or combinedwith radiopaque materials and markers to aid the placement, adjustmentsand repositioning of the intravascular implant 2 and associated partswith the use of an angiogram.

FIG. 34 illustrates an embodiment of the connector 4 and the anchor 10that can have a contraction line 193 releasably connected to the anchorcollar 150. Contraction line 193 can be formed of coaxial hypotubes.Contraction line 193 can also be part of control line 172. The arms 14can be biased to radially expand or radially contract. FIG. 35illustrates that the contraction line 193 can be pulled, as shown byarrow 194, which can result in a distal movement of the anchor collar150, as shown by arrow 196. The distal movement of the anchor collar 150can cause the arm supports 154 and, in turn, the arms 14 to rotateinward and radially contract, as shown by arrows 198. The above processcan be reversed and the arms 14 can be radially expanded. Thecontraction line can be separated from the anchor collar 150 whenplacement of the anchor 10 is finalized.

FIG. 36 illustrates an embodiment of the connector 4 and the anchor 10that can have a fixed hub 200 that is fixedly held in space, for exampleby the seal 20, the delivery catheter 168 and/or the control line 172,distal to the anchor collar 150. The fixed hub 200 can also be slidablyconnected to the connector 4. FIG. 37 illustrates that the connector 4can be pulled distally, as shown by arrow 202, which can cause theanchor collar 150 to butt against the fixed hub 200 and be forcedproximally with respect to the connector 4, as shown by arrow 204. Theproximal movement of the anchor collar 150 can cause outward rotationand radial expansion of the arm supports 154 and, in turn, the arms 14,as shown by arrows 206. The above process can be reversed and the arms14 can be radially contracted. The arms 14 can be locked into place bymethods known to those having ordinary skill in the art.

FIG. 38 illustrates that the catheter 168 can be retracted distally ofthe seal 20, as shown by arrows 208. Retracting the catheter 168 canexpose the seal 20, allowing the seal 20 to radially expand, as shown byarrows 210. The seal 20 can be placed to seat in the proximal neck 176.When fully deployed, the intravascular implant 2 can have an open-walledstructure, and can therefore be placed adjacent to the transversevessels 180 without interfering with the flow through the transversevessels 180.

FIG. 39 illustrates the intravascular implant 2 that can be implanted inthe vascular site 170. The distal end 26 can be attached to a secondimplant 28, for example a vascular graft such as an abdominal aorticaneurysm graft, for example a gel weave aortic graft. The second implant28 can have two branching legs 212.

FIG. 40 illustrates a cross-section of an embodiment of the attachmentdevice 22 and second end 8 of the seal 4. The seal ring 30 can beproximal to the slides 100. The seal cover 34 or the second implant 28can extend from the seal ring 30. FIG. 41 illustrates pulling the sealring 30 along the slides 100, as shown by arrows 214. Movement of theseal ring 30 along the slides 100 can cause the seal ring to radiallycontract, as shown by arrows 216. Once the seal ring 30 is distallyclear of the slides 100, the seal ring 30 can radially expand, as shownby arrows 218, and seat into the catch 104. Once in the catch 104, theseal ring 30 can be held vertically in place by the distal side of theslide 100 and the proximal side of the interference piece 102.

As illustrated in FIG. 43, the second implant 28 can be attached to theseal ring 30 at the proximal end of the second implant 28. The seal ring30 can be releasably attached to deployment rods 220.

As illustrated in FIG. 44, the deployment rods 220 can be used toposition the seal ring 30 proximal to the attachment device 22 and sothat the deployment rods 220 align into the rod slots 112. (The secondimplant 28 is not shown in FIG. 44 for clarity). The deployment rods 220can be pulled distally, as shown by arrow 222, thereby moving the sealring 30 distally. As illustrated in FIG. 45, the seal ring 30 can thenseat into the catch 104. The deployment rods 220 can be detached fromthe seal ring 30 and removed from the vascular site 170. The controlline 172 can be removed from the vascular site 170 whenever removal isdeemed appropriate during the implantation procedure.

FIG. 46 illustrates an embodiment of the intravascular implant 2deployed at a vascular site 170. The vascular site 170 can have aseverely tortuous region over which the implant 2 is placed. Theflexibility of the connector 4 compensates for the contortion in thevascular site, enabling the arms 14 to intersect the wall of thevascular site 170 at a substantially perpendicular angle, and enablingthe seal 20 to seat into the proximal neck 176 to open into the at asubstantially parallel angle to the body of the second implant 28.Stress and fractures in the intravascular implant 2 and in the tissue atthe vascular site 170 can be minimized due to the anchor 10 beingmechanically insulated from the seal 20 by use of the connector 4.Additionally, stresses can be reduced because the tissue in the vascularsite 170 adjacent to the anchor 10 does not need to seal, and the tissuein the vascular site 170 adjacent to the seal 20 does not need toanchor. Additional intravascular implants 2, as shown, can be deployedat the distal ends 224 of the second implant 2, for example in the iliacarteries, to additionally secure the second implant 2.

The arms 14 and/or the seal 20 can apply chronic stress to the adjacenttissue in the vascular site 170 causing a controlled migration of thearms 14 and/or seal 20 into the wall of the vascular site 170 to aspecified depth predetermined by the tissue mainstays 33 and/or 148. Thepredetermined depth can be the length of the tissue mainstay 33 and/or148, or a force exerted by the tissue mainstay 33 and/or 148. Thecontrolled migration is then halted by either a distribution of forcealong the greater surface area between the tissue mainstay 33 and/or 148and the wall of the vascular site or the diminishing force on the samesurface area once the radially central end (with respect to the anchor10) of the tissue mainstay 33 and/or 148 has reached the wall of thevascular site 170, or a combination of both. Tissue can then ingrowaround the tissue mainstay 33 and/or 148 providing a biologic seal oranchor so that the integrity of the seal or anchor is not purelymechanical.

It is apparent to one having ordinary skill in the art that variouschanges and modifications can be made to this disclosure, andequivalents employed, without departing from the spirit and scope of theinvention. Elements shown with any embodiment are exemplary for thespecific embodiment and can be used on other embodiments within thisdisclosure.

1. A device for treating an aneurysm having a longitudinal axis, thedevice comprising: a vascular graft comprising a seal and a tubularchannel having a first end and a second end; and an expandable anchorattached to the first end of the tubular channel, wherein the expandableanchor comprises a first anchor arm, wherein the first anchor armextends at least partially in a longitudinal direction away from thefirst end of the tubular channel, wherein the first anchor arm extendsat least partially radially outward relative to the longitudinal axis,wherein the first anchor arm comprises a first anchor arm first portionhaving a first radius from the longitudinal axis and a first anchor armsecond portion having a second radius from the longitudinal axis,wherein the first anchor arm second portion is further from the firstend of the tubular channel than the first anchor arm first portion, andwherein the second radius is greater than the first radius, wherein theseal comprises a first seal portion and a second seal portion, whereinthe first seal portion is separated from the second seal portion by afirst length of material and a second length of material, wherein thefirst seal portion has a first portion radius measured from thelongitudinal axis to a furthest point on an exterior surface of thefirst seal portion, wherein the second seal portion has a second portionradius measured from the longitudinal axis to the furthest point on anexterior surface of the second seal portion, wherein the first length ofmaterial has a first length of material radius measured from thelongitudinal axis to the furthest point along an exterior surface of thefirst length of material, wherein the second length of material has asecond length of material radius measured from the longitudinal axis tothe farthest point along an exterior surface of the second length ofmaterial, wherein the first portion radius is greater than the firstlength of material radius and the second length of material radius, andwherein the second portion radius is greater than the first length ofmaterial radius and the second length of material radius.
 2. The deviceof claim 1, wherein the first anchor arm second portion is placeableagainst a blood vessel wall.
 3. The device of claim 1, wherein the firstanchor arm first and second portions are placeable against a bloodvessel wall.
 4. The device of claim 1, wherein the expandable anchor isconfigured to allow fluid to flow through the vascular graft when theexpandable anchor is in an expanded configuration.
 5. The device ofclaim 1, wherein the expandable anchor comprises a second anchor arm,wherein the second anchor arm extends at least partially in alongitudinal direction away from the first end of the tubular channel,wherein the second anchor arm extends at least partially radiallyoutward relative to the longitudinal axis, wherein the second anchor armcomprises a second anchor arm first portion having a third radius fromthe longitudinal axis and a second anchor arm second portion having afourth radius from the longitudinal axis, wherein the second anchor armsecond portion is further from the first end of the tubular channel thanthe second anchor arm first portion, and wherein the fourth radius isgreater than the third radius.
 6. The device of claim 1, wherein theexpandable anchor comprises a second anchor arm, wherein the secondanchor arm extends at least partially in a longitudinal direction awayfrom the first end of the tubular channel, wherein the second anchor armextends at least partially radially outward relative to the longitudinalaxis, wherein the second anchor arm comprises a second anchor arm firstportion having a third radius from the longitudinal axis and a secondanchor arm second portion having a fourth radius from the longitudinalaxis, wherein the second anchor arm first portion is further from thefirst end of the tubular channel than the second anchor arm secondportion, and wherein the fourth radius is less than the third radius. 7.The device of claim 1, wherein the seal is configured to assist inholding the vascular graft in place within a blood vessel of a patient.8. The device of claim 1, wherein the vascular graft is placeable acrossan abdominal aortic aneurysm.
 9. A device for treating an aneurysmhaving a longitudinal axis, the device comprising: a vascular graftcomprising a seal and a tubular channel having a first end and a secondend; and an expandable anchor attached to the first end of the tubularchannel, wherein the expandable anchor comprises a first connector and afirst anchor arm, wherein the first anchor arm extends at leastpartially in a longitudinal direction away from the first end of thetubular channel, wherein the first anchor arm extends at least partiallyoutward relative to the longitudinal axis and the first connector,wherein the first anchor arm comprises a first anchor arm first portionand a first anchor arm second portion, wherein the first anchor armfirst portion has a first distance from the longitudinal axis and thefirst connector, wherein the first anchor arm second portion has asecond distance from the longitudinal axis, wherein the first anchor armfirst portion is further from the first end of the tubular channel thanthe first anchor arm second portion, wherein the second distance is lessthan the first distance, and wherein the first anchor arm first portionis attached to the first connector, wherein the seal comprises a firstseal portion and a second seal portion, wherein the first seal portionis separated from the second seal portion by a first length of materialand a second length of material, and wherein the first and second sealportions are inflatable.
 10. The device of claim 9, wherein the firstanchor arm second portion is placeable against a blood vessel wall. 11.The device of claim 9, wherein the first anchor arm first and secondportions are placeable against a blood vessel wall.
 12. The device ofclaim 9, wherein the expandable anchor is configured to allow fluid toflow through the vascular graft when the expandable anchor is in anexpanded configuration.
 13. The device of claim 9, wherein theexpandable anchor comprises a second connector and a second anchor arm,wherein the second anchor arm extends at least partially in alongitudinal direction away from the first end of the tubular channel,wherein the second anchor arm extends at least partially outwardrelative to the longitudinal axis and the second connector, wherein thesecond anchor arm comprises a second anchor arm first portion and asecond anchor arm second portion, wherein the second anchor arm firstportion has a first distance from the longitudinal axis and the secondconnector, wherein the second anchor arm second portion has a seconddistance from the longitudinal axis, wherein the second anchor armsecond portion is further from the first end of the tubular channel thanthe second anchor arm first portion, wherein the fourth distance isgreater than the third distance, and wherein the second anchor arm firstportion is attached to the second connector.
 14. The device of claim 9,wherein the expandable anchor comprises a second connector and a secondanchor arm, wherein the second anchor arm extends at least partially ina longitudinal direction away from the first end of the tubular channel,wherein the second anchor arm extends at least partially outwardrelative to the longitudinal axis and the second connector, wherein thesecond anchor arm comprises a second anchor arm first portion and asecond anchor arm second portion, wherein the second anchor arm firstportion has a first distance from the longitudinal axis and the secondconnector, wherein the second anchor arm second portion has a seconddistance from the longitudinal axis, wherein the second anchor arm firstportion is further from the first end of the tubular channel than thesecond anchor arm second portion, wherein the fourth distance is lessthan the third distance, and wherein the second anchor arm first portionis attached to the second connector.
 15. The device of claim 9, whereinthe seal is configured to assist in holding the vascular graft in placewithin a blood vessel of a patient.
 16. The device of claim 9, whereinthe vascular graft is placeable across an abdominal aortic aneurysm. 17.A device for treating an aneurysm having a longitudinal axis, the devicecomprising: a vascular graft comprising a fillable seal and a tubularchannel having a first end and a second end; and an expandable anchorattached to the first end of the tubular channel, wherein the expandableanchor comprises a first anchor arm, wherein the first anchor armextends at least partially in a longitudinal direction away from thefirst end of the tubular channel, wherein the first anchor arm extendsat least partially outward relative to the longitudinal axis, whereinthe first anchor arm comprises a first anchor arm first portion having afirst distance from the longitudinal axis and a first anchor arm secondportion having a second distance from the longitudinal axis, wherein thefirst anchor arm first portion is closer to the first end of the tubularchannel than the first anchor arm second portion, and wherein the seconddistance is greater than the first distance, wherein the fillable sealhas an unfilled configuration and a filled configuration, wherein whenthe fillable seal is in the filled configuration the fillable seal isfilled with a material, and wherein when the fillable seal is in thefilled configuration the material extends at least partially around thelongitudinal axis.
 18. The device of claim 17, wherein at least one ofthe first anchor arm first portion and the first anchor arm secondportion is placeable against a blood vessel wall, and wherein theexpandable anchor is configured to allow fluid to flow through thevascular graft when the expandable anchor is in an expandedconfiguration.
 19. The device of claim 17, wherein the expandable anchorcomprises a second anchor arm, wherein the second anchor arm extends atleast partially in a longitudinal direction away from the first end ofthe tubular channel, wherein the second anchor arm extends at leastpartially outward relative to the longitudinal axis, wherein the secondanchor arm comprises a second anchor arm first portion having a thirddistance from the longitudinal axis and a second anchor arm secondportion having a fourth distance from the longitudinal axis, wherein thesecond anchor arm second portion is further from the first end of thetubular channel than the second anchor arm first portion, and whereinthe fourth distance is greater than the third distance.
 20. The deviceof claim 17, wherein the expandable anchor comprises a second anchorarm, wherein the second anchor arm extends at least partially in alongitudinal direction away from the first end of the tubular channel,wherein the second anchor arm extends at least partially outwardrelative to the longitudinal axis, wherein the second anchor armcomprises a second anchor arm first portion having a third distance fromthe longitudinal axis and a second anchor arm second portion having afourth distance from the longitudinal axis, wherein the second anchorarm first portion is further from the first end of the tubular channelthan the second anchor arm second portion, and wherein the fourthdistance is less than the third distance.